FDA recall, , Moderate risk
Beckman Coulter CellMek SPS Sample Preparation System
The CellMek SPS Sample Preparation System has a software error that can cause sample loss and incorrect diagnosis.
Summary by Recall Canary from the FDA notice
What happened
Beckman Coulter, Inc., of Miami, Florida, began a recall of the CellMek SPS Sample Preparation System, REF: C44603, with software, on December 23, 2025.
The system, designed to automate staining, lysing, and cell washing, has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge the fluid line, result in sample loss and spillage, make the instrument inoperable, and lead to unintentional removal of 60-100 microliters from the final sample, potentially causing incorrect diagnosis or patient management.
The FDA added the recall to its Enforcement Report and classified it on February 2, 2026, with distribution in the U.S. states of Alabama, Delaware, Illinois, Massachusetts, Missouri, Oregon, and Washington, and worldwide in countries including AB, BE, ES, FR, NL, ON, DE, AT, VIC, AU, GB, SK, MX, and CH.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
CellMek SPS Sample Preparation System, REF: C44603, with software
- UDI-DI
- 15099590750312
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Missouri, Washington, Massachusetts, Illinois, Alabama, Oregon, Illinois and the countries of AB, BE, ES, FR, NL, ON, Delaware, AT, VIC, AU, GB, SK, MX, CH.
- Company
- Beckman Coulter, Inc.Miami, Florida
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98207
- Recall number
- Z-1235-2026
All recalls from Beckman Coulter, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
